SAN ANTONIO, TEXAS, 14 December, 2007 – New data presented today at the San Antonio Breast Cancer Symposium (SABCS) show that adding Xeloda (capecitabine) to the current gold standard combination of Herceptin (trastuzumab) and docetaxel allows patients with advanced HER2-positive breast cancer to live, on average 5 months longer until their cancer starts to grow. The addition of capecitabine in this setting represents an important advance in the treatment of an aggressive form of breast cancer and provides additional hope to women with an otherwise poor prognosis.
“Trastuzumab’s ability to increase survival changed the treatment landscape for advanced breast cancer patients, and now adding capecitabine to the most commonly used first-line regimen of trastuzumab and taxanes allows patients to live even longer without their disease progressing,” said Dr Andrew Wardley, lead investigator of the study and Consultant Medical Oncologist from the Christie Hospital in the UK. “As capecitabine is an oral chemotherapy that can be taken at home, the additional therapy does not increase the time patients spend in the hospital. This is a tremendous benefit for patients, which translates into better one and two-year survival rates for the triple combination.”
The results of the CHAT study (Capecitabine, Herceptin and Taxotere) show the addition of capecitabine significantly improves two important measures of treatment efficacy. One measure evaluates the amount of time from the start of treatment until tumour growth, known as time to progression (TTP), the other measures the amount of time from the start of treatment until tumour growth or death, known as progression-free survival (PFS). The observed improvement in both these measures for the CHAT study was both statistically and clinically significant - an improvement in both these measures means that patients are living for longer with their cancer under control.
Results of the CHAT study show that with the addition of capecitabine: • The median TTP increased from 13.6 to 18.6 months (p-value = 0.0295); • The median PFS increased from 12.8 months to 17.9 months (p-value = 0.0402). In HER2-positive breast cancer, trastuzumab not only offers the best chance of a cure in early disease, but also has proven survival benefits in advanced disease. The study evaluated the addition of oral capecitabine to trastuzumab and docetaxel in patients with HER2-positive breast cancer who were previously untreated for their locally advanced, or metastatic, disease. Additional analysis showed that when capecitabine is added to the trastuzumab and docetaxel combination, there is a 7 percent improvement in complete response, from 16 to 23 percent. Currently the median overall survival for the study is close to 4 years, although data is immature this is one of the longest overall survival rates seen in HER2-positive breast cancer patients whose disease has spread.
Breast cancer is the leading cause of cancer deaths worldwide in women under the age of 55 and more than one million women are diagnosed with breast cancer each year. HER2-positive breast cancer, which affects approximately 20-30 percent of women with breast cancer, demands immediate attention because the tumours are fast-growing and there is a high likelihood of relapse.
Xeloda is a highly effective and innovative oral chemotherapy drug that targets the cancer-killing agent 5-FU (5-fluorouracil) directly at the site of cancer cells without the inconvenience and burden of traditional intravenous (i.v.) therapy. The unique way in which Xeloda works provides women who have breast cancer with a powerful treatment that has a better side-effect profile compared to i.v. chemotherapy.
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